Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)

NCT02945462 | Completed Phase 1

• 1 other identifier: EDUJCTC
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recovery of erectile function using bone marrow mesenchymal stem cells (MSCs) after in vitro expansion under restricted culturing conditions.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Observation of any relevant adverse side effect resulting from the injection. Assessing the safety of autologous Mesenchymal Stem Cells injection

  six months

Secondary Outcomes (2)

• Assessment the efficacy of intracavernous injection measured by SHIM/IIEF/EHS questionnaire

  18 months

• Evaluation the efficacy of intracavernous injection measured by Dynamic Infusion cavernosometry test.

  6 months

Study Arms (1)

autologous mesenchymal stem cells

EXPERIMENTAL

Intervention: Autologous bone marrow derived stem cells will be injected twice intracavernously to enrolled erectile dysfunction patients

Biological: autologous mesenchymal stem cells

Interventions

autologous mesenchymal stem cells BIOLOGICAL

Patients will be injected with autologous mesenchymal stem cells, intracavernously

autologous mesenchymal stem cells

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male patients ranging from 25 to 65 years.
• Type 1 or type 2 diabetic patients with a personal history of diabetes ≥ 5 years.
• History of chronic erectile dysfunction for at least six months.
• HbA1c ≤ 10%.
• Baseline International Index of Erectile Function (IIEF) score of \< 26.
• Not interested or able to use Phosphodiesterase type 5 inhibitor (PDE-5i) drug therapy and willing to forgo these treatments for the first 6 month period following study treatment.
• Body mass index between 20 -30.
• Willing to provide written informed consent, complete questionnaire, and to be available for all baseline treatment and follow up examinations required by protocol.

You may not qualify if:

• Untreated hypogonadism or low serum total testosterone \< 200 ng/dl.
• Current urinary tract or bladder infection.
• Any medical evidence of any infectious disease.
• Clinically evident penile anatomical deformities (e.g., Peyronie's disease) or history of priapism.
• Skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection.
• Current or previous malignancy.
• Patients with primary hyperlipidemia.
• Use of any non study treatment for erectile dysfunction within 4 weeks of study treatment.
• Lack of willingness to continue through 6 months after study treatment.
• Any previous penile implant or penile vascular surgery.
• Uncontrolled hypertension or hypotension (systolic blood pressure \> 170 or \< 90 mm Hg, and diastolic blood pressure \> 100 or \< 50 mm Hg).
• Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening.
• Bleeding or clotting disorder, use of anticoagulant therapy.
• Lab values for complete blood count, prothrombin time/ partial thromboplastin time/international randomized ratio (PT/PTT/INR), Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine falling outside the normal lab values.
• Systemic autoimmune disorder.

Sponsors & Collaborators

• University of Jordan: lead

Related Publications (1)

• Al Demour S, Adwan S, Jafar H, Alhawari H, Awidi A. Stem cell therapy in diabetic men with erectile dysfunction: a 24-month follow-up of safety and efficacy of two intracavernous autologous bone marrow derived mesenchymal stem cells injections, an open label phase 2 clinical trial. Basic Clin Androl. 2024 Jul 5;34(1):13. doi: 10.1186/s12610-024-00229-y.

  PMID: 38965462 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 26, 2016
• Study Start: September 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: October 1, 2016
• Last Updated: November 16, 2016

Record last verified: 2016-11